AUSTRALIAN GOLD DEFENSE ZONE ANTI-DANDRUFF STEP 2- pyrithione zinc shampoo 
Prime Enterprises, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredients

Pyrithione Zinc 1%

Purpose

Antidanruff

Uses

Warnings

For external use only.

When using this product

  • Avoid contact with the eyes. If contact occurs, rinse eyes thorougly with water.

Stop use and ask a doctor if

  • If Condition worsens or does not improve after regular use of this product as directed

Keep out of reach of children.

  • If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive Ingrediets:

Acrylates Copolymer, Caprylyl Glycol, Chlorphenesin, Citric Acid, Cocamide MEA, Cocamidopropyl Betaine, Dimethicone, Disodium EDTA, Fragrance, Glycol Stearate, Phenoxyethanol, Sodium Chloride, Sodium Hydroxide, Sodium Laureth Sulfate, Stearyl Dihydroxypropyldimonium Oligosaccharides, Water

Questions or Comments?

Call toll free 1-855-548-4653

PRINCIPAL DISPLAY PANEL - 266 mL  Bottle Label
PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label

PRINCIPAL DISPLAY PANEL - 266 mL Bottle Label

Defense

Zone

Medicated 2 in 1

Shampoo &

Conditioner

Anti-Dandruff

Step

2

Gradual Release

Provides Long Lating Results

9 FL OZ (266mL)

PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label

Defense

Zone

Medicated

2 in 1

Shampoo &

Conditioner

Anti-Dandruff

Step

2

Gradual Release

2 FL OZ (59mL)

PRINCIPAL DISPLAY PANEL- 59 mL Bottle

Defense

Zone

Medicated

 2 in 1

Shampoo &

Conditioner

Anti-Dandruff

Step

2

Gradual Release

2 FL OZ (59mL)

AUSTRALIAN GOLD DEFENSE ZONE  ANTI-DANDRUFF STEP 2
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0180
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10.32 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCOL STEARATE (UNII: 0324G66D0E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0180-5266 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2015
2NDC:58443-0180-359 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H06/01/2015
Labeler - Prime Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028label(58443-0180) , pack(58443-0180) , manufacture(58443-0180) , analysis(58443-0180)

Revised: 1/2020
Document Id: 9c59436c-7be6-3cf8-e053-2a95a90a2863
Set id: d20ff9f8-fcdc-4fcc-af2f-8db5415a6e6b
Version: 4
Effective Time: 20200117
 
Prime Enterprises, Inc.